# E-Z-Em, Inc.

- Location (FDA's records): Westbury, NY
- FDA decisions: 56 (1977–2007): 56 510(k) clearances
- Product codes: FCX (4), HIO (3), FPA (3), KNT (3), JAK (3), DQO (2), DSB (2), GDF (2), IZQ (2), FGD (2), LYR (2), DQX (2)
- Predicates its devices cite: 8 (7 its own); citations of its devices by later devices: 27 (7 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Venospital, Inc.: 1 (https://510kreport.com/company/venospital)

## Firms that cite its devices most
- Bracco Diagnostic, Inc.: 4 (https://510kreport.com/company/bracco-diagnostic)
- Ferguson Medical: 2 (https://510kreport.com/company/ferguson-medical)
- Coeur, Inc.: 2 (https://510kreport.com/company/coeur)
- Lexion Medical, LLC: 2 (https://510kreport.com/company/lexion-medical)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Byrne Medical, Inc.: 1 (https://510kreport.com/company/byrne-medical)
- Hakko Medical Co., Ltd.: 1 (https://510kreport.com/company/hakko-medical)

## Its most-cited devices
- K053008: E-Z-EM Endoscopic CO2 Regulator (2005), cited by 6
- K030854: PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 (2003), cited by 3
- K011160: E-Z EM Percupump 2001 CT Injector (2001), cited by 3
- K013219: PROTOCO2L Insufflator Model 6400 (2002), cited by 2
- K031571: Empowercta Injector System, Models 9930 & 9910 & 9825 (2003), cited by 2
- K882601: E-Z-EM (R) Lufkin Biopsy Needles (1988), cited by 2

## Recent decisions
- K071378: Modification to Empower CT/Cta Injector System, Models 9800/9900 Product Series (Jun 13, 2007)
- K062449: Empowermr Injector System, Model 9730 (Apr 13, 2007)
- K063029: Empower CT/Cta Injector System, Model 9800/9900 (Nov 2, 2006)
- K053008: E-Z-EM Endoscopic CO2 Regulator (Dec 27, 2005)
- K041178: Empower Transfer Set, (Cat. NO. 7725) (Jul 16, 2004)
- K031571: Empowercta Injector System, Models 9930 & 9910 & 9825 (Jun 19, 2003)
- K030854: PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 (Apr 16, 2003)
- K013219: PROTOCO2L Insufflator Model 6400 (Feb 19, 2002)

Source page: https://510kreport.com/company/e-z-em